Verfahren zur Trennung von Vollen und Leeren Aav-Partikeln

Details

Veröffentlichungs-Nr.

EP4744752

Anmeldetag

11. September 2023

Veröffentlichung

20. Mai 2026

Rechtsraum

EP

IPC

(KHATWANI SANTOSHKUMAR et al.)(HANAK JULIAN et al.)(PREC BIOSCIENCES INC et al.)

Abstract

Herein is reported a method for separating full and empty recombinant adeno-associated virus particles using an anion exchange chromatography step, wherein the method comprises a sequence of a applying a solution comprising empty and/or full rAAV particles to an anion exchange chromatography material inside a chromatography column, a first isocratic step, a first linear gradient, a second isocratic step and a second linear gradient, wherein the empty recombinant adeno-associated virus particles are eluted during the first linear gradient and the full recombinant adeno-associated virus particles are eluted during the second linear gradient. In certain embodiments, the solution applied in the first isocratic step comprises about 65 mM of the buffer substance, about 10 mM of the elution salt, about 2 mM of the salt and has a pH value of about 9.4. In certain embodiments, the solution applied in the second isocratic step comprises about 65 mM of the buffer substance, about 90 mM of the elution salt, about 2 mM of the salt and has a pH value of about 9.4. In certain embodiments, the buffer substance is N-(1,1-Dimethyl-2-hydroxyethyl)-3-amino-2-hydroxypropane sulfonic acid, the elution salt is tetramethyl ammonium chloride, and the salt is magnesium chloride.

Anmelder

Firma

F. Hoffmann-La Roche AG

Land

🇨🇭 Schweiz